Medical device and method for preventing adhesions

ABSTRACT

Methods and devices for treatment of a uterine cavity to prevent adhesions following a surgical intervention.

RELATED APPLICATION

This application claims benefit of U.S. provisional application62/959,686 filed on Jan. 10, 2020, the entirety of which is incorporatedby reference.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates to an intra-uterine device adapted fortemporary placement in a uterine cavity to prevent adhesions following asurgical intervention.

2. Description of the Background Art

Following a gynecological procedure or surgery, such as a myomectomy,polyp removal, ablation, curettage or another uterine surgery, afrequent complication are post-surgical adhesions between anterior andposterior walls of the uterus.

SUMMARY

The present disclosure includes methods and devices for treating auterine cavity. For example, the treatment can include a uterine cavitythat is injured following a medical procedure or other trauma thatcauses bleeding therein. In one example, a method for treating a uterinecavity includes deploying a device within the uterine cavity in adelivery profile, the device having a contact surface carrying a firstpharmacological agent; expanding the device to cause the contact surfaceto move into an expanded profile where the contact surface engages asurface of the uterine cavity to tamponade a bleeding at the surface ofthe uterine cavity and such that the first pharmacological agentreleases from the contact surface into the surface of the uterine cavityover a first interval; collapsing the device to a collapsed profile toprovide a barrier between uterine cavity surfaces wherein a secondpharmacological agent releases from the contact surfaces over a secondinterval; and removing the device after the second interval.

Variations of the method can include a second interval that begins aftera first interval ends. Alternatively, the intervals can overlap or canbe spaced in time.

The first pharmacological agents can be selected from a group constatingof a hemostatic agent, an analgesic agent, an anti-cramping agent, and anon-steroidal anti-inflammatory agent. The second pharmacological agentcan be selected from a group consisting of an anti-adhesion agent, ananalgesic agent, an anti-cramping agent, and a non-steroidalanti-inflammatory agent. However, the disclosure includes the use of anypharmacologic, biologic, or medicinal agent as needed.

As noted above, the uterine cavity can include one or more regions oftissue that are damaged, including but not limited to tissue that isdamaged after a therapeutic procedure. Such procedures can includeresection, curettage and/or ablation of tissue.

In an additional variation of the method deploying the device includestrans-cervically introducing an elongate introducer into the uterinecavity and deploying the device from a passageway in the elongateintroducer.

Variations of the methods and device can include deploying the deviceusing a spring-like element in the device to expand the device to atriangular shape in the uterine cavity.

In an additional variation of methods described herein include deployingthe device includes removing introducer from a uterus and a cervix andleaving a tether extending through a cervical canal, where the tether isconnected to the device.

Expanding the device can include inflating the device with a fluidinjected through a lumen of a tether coupled to an interior chamber ofthe device. However, any inflation or expansion means is within thescope of this disclosure. Once expanded, the device can be maintained inthe expanded position by sealing the lumen of the tether. Additionalvariations of the tether can include an actuatable a stop mechanism in aportion of the tether outside the uterine cavity, inside the uterinecavity, or at any location relative to the device. In such cases,releasing the device to reduce the expanded profile can compriseactuating the stop mechanism to unseal the lumen.

Additional pharmacological agents can be dispensed through a secondtether channel into the uterine cavity.

In an additional variation, the device can be removed from the uterinecavity after the second interval. For example, removal can occur bypulling a tether or other structure coupled to the device outwardly froma cervical canal and uterine cavity.

The present disclosure further includes devices configured for temporaryimplantation in a uterine cavity following a medical procedure therein.For example, such a device can include a tissue contacting structurebeing moveable between a deployment configuration, a collapsed,configuration, and an expanded configuration in which the tissuecontacting structure engages a surface of the uterine cavity; where thetissue contacting structure comprises a thin film member disposed arounda spring element; and at least one pharmacological agent located on orin the thin film member and configured to be releasable from a surfaceof the thin film member over a time release interval.

Variations of the device can include a thin film member that has a fluidtight interior chamber to allow inflation of the thin film member. Asnoted above, the devices can include one or more tethers for inflation,delivery of substances, and/or retrieval of the device from the uterinecavity. Moreover, one or more of the tethers can include an inflationballoon therein adapted for coupling to an inflation source.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a variation of the present invention which consistsof an expandable-collapsible anti-adhesion device adapted for temporarydeployment in a patient's uterus together with an introducer that isconfigured for trans-cervical introduction of the anti-adhesion deviceinto a patient's uterus.

FIG. 2A is a schematic view of the patient's uterus with the fibroid inthe uterine wall, and an endoscope and resection device in phantom viewintroduced through the cervical canal into the uterine cavity to resectthe fibroid in a myomectomy procedure.

FIG. 2B is a subsequent view of the patient's uterus after the fibroidhas been resected with the resecting device, again shown in phantomview.

FIG. 3A is a subsequent view of the patient's uterus as in FIGS. 2A-2Bafter removal of the endoscope and resection device further showinginitial step in the method of the invention which consists of thetrans-cervical introduction of an elongated introducer sleeve of thepresent invention that carries a deployable anti-adhesion device.

FIG. 3B illustrates another step of the invention comprising an initialstage of the deployment of the anti-adhesion adhesion device of theinvention, wherein the introducer sleeve is withdrawn to deploy theanti-adhesion device.

FIG. 3C illustrates a subsequent step of the invention comprising thefull deployment of the anti-adhesion adhesion device following furtherretraction of the introducer sleeve into the cervical canal.

FIG. 3D illustrates a subsequent step of the invention comprising thedeployment of the anti-adhesion adhesion device following removal of theintroducer sleeve altogether which leaves a tether in place, and thefurther step of inflating the anti-adhesion device.

FIG. 3E illustrates a final step in a method of using the inventionwhich comprising pulling on tether to remove the anti-adhesion devicefrom the patient's uterus.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIG. 1, in anti-adhesion system 100 corresponding to thepresent invention is shown which consists of an expandable-collapsibledevice 105 and an elongate introducer 110. The anti-adhesion device 105when expanded and deployed in a patient's uterus has drug-deliverysurfaces 111 that engage and contact the walls 112 of the patient'suterus 114 (see FIG. 3C). In one variation, the anti-adhesion device 105consists of a thin film member 115 that can be elastomeric ornon-elastomeric and is laterally expandable from a collapsed state to anexpanded state by an interior spring element 120. In one variation, thespring element 120 is a wire or flat ribbon member that has resilientspring characteristics capable of expanding the thin film member 115 toits expanded state or shape.

In the variation shown in FIG. 1, the thin film member 115 surrounds thespring element 120 and comprises an inflatable structure, which can beinflated and expanded by a liquid or gas from an inflation source 125following deployment in a patient's uterus. As can be seen in FIG. 1, atether 140 is coupled to a proximal end 142 of the thin wall member anddevice 105. In one variation, the tether 140 is tubular and has aninterior lumen 144 for coupling to the inflation source 125 forinflating the anti-adhesion device. Thus, the spring element 120 canassist in the lateral expansion of the anti-adhesion device 105 and theinflation source 125 can further assist in expanding the thickness ofthe device 105 to ensure contact of the outer surface 111 of the thinfilm member 115 with the uterine cavity walls for tamponading theuterine cavity wall following a resection procedure.

Still referring to FIG. 1, it can be understood that the anti-adhesiondevice 105 can be collapsed and carried in the interior passageway 148of a thin wall introducer member 110. Further, the introducer 110 has ahandle 150 and carries an internal pusher member or rod 158 for pushingthe anti-adhesion device 105 outwardly from the interior passageway 148.As will be described below, the manual withdrawal of the introducer 110while maintaining the pusher member 158 in place can be used to deploythe anti-adhesion device 105 in the patient's uterus. In one variation,the elongated introducer 110 consists of a sleeve fabricated of aplastic or metal having a length suited for extending through thepatient's cervical canal 164 and the length of the uterine cavity 114(FIG. 3A). The outer diameter of the introducer 110 can be 5 mm or lessand is often 3 mm in diameter or less.

The anti-adhesion device 105 is adapted to perform multiple functionswhich may be necessary to prevent or eliminate the potential foradhesions in a patient's uterus following a surgical procedure such as amyomectomy, polyp removal, ablation or other surgical treatment. In afirst aspect of the invention, the inflation of the thin film member 115can be used as a tamponade in the uterus following a resection procedureas will be described further below.

In a second aspect of the invention, the outer surface of the thin filmlayer and edges of the device carry at least one pharmaceutical agentadapted to provide a hemostatic effect. More in particular, the outersurface of the thin film member 115 is adapted for time-release of thehemostatic agent(s) within a 24-hour period following deployment in thepatient's uterus. Such hemostatic agents or coagulants may act on bloodcoagulation pathways in different manners to prevent or promote bloodclot formation, many of which are known in the art. The controlled,timed-release aspect of the invention can be provided by anybioerodible, dissolvable, or bioresorbable coating on the device thatcarries the hemostatic agents.

In a third aspect of the invention, the outer surface of the thin filmmember carries one or more additional pharmaceutical agents there areadapted to provide at least one of an anti-inflammatory effect, painrelief, or an anti-cramping effect. Anti-inflammatory drugs such asNSAIDs well known in the art. These agents are adapted for release fromthe surface of the device within an interval ending after 72 hoursfollowing deployment in the patient's uterus. The time release aspectagain can be provided by leaders of the bioerodible, bioabsorbable orresorbable coatings on the thin film member.

In another aspect of the invention, the outer surface of theanti-adhesion device 105 can carry one or more other pharmaceuticalagents adapted to provide anti-cramping that extend to 28 days followingdeployment in a patient's uterus. In other words, the coatings on thesurface of the thin film member can include 2 or 3 different layers thatoffer time release of different pharmacological agents over time.

Now turning to FIGS. 2A-2B and FIGS. 3A-3E, a number of steps relatingto a method of the invention are illustrated. FIG. 2A is a schematicsectional view of a patient's uterus 115 with a fibroid 170 in theuterine wall 112. In FIG. 2A, an endoscope 172 and resection device 175are shown in phantom view introduced through the cervical canal 164 intothe uterine cavity to resect the fibroid 170 in a myomectomy procedure.The resection device 175 can be a tubular cutter is known in the art.FIG. 2B is a subsequent view of the patient's uterus 114 after thefibroid 170 has been resected with the resecting device, indicating aresected wall surface 177 that may be bleeding. The endoscope 172 andresection device 175 are again shown in phantom view.

Now referring to FIGS. 3A-3E, the steps of a method of the invention areillustrated. In FIG. 3A, the elongate introducer 110 carrying thecollapsed anti-adhesion device 105 is introduced through the patient'scervical canal 164 into the patient's uterine cavity. In FIG. 3B, it canbe seen that the elongate introducer 110 is withdrawn in the proximaldirection while the pusher member or rod 158 is held stationary whichdeploys the anti-adhesion device 105 outwardly from the distal tip 182of the introducer 110.

Now turning to FIG. 3C, introducer 100 is fully retracted and the pusherrod 158 remains stationary to thereby fully deploy the device 105outwardly from the distal tip 182 of the introducer 110. FIG. 3C thatshows the anti-adhesion device 105 fully deployed with the spring member120 expanding the device into its triangular shape in the uterinecavity.

FIG. 3D next shows the anti-adhesion device 105 deployed with theintroducer 110 completely removed from the patient's body which therebyleaves a tubular tether 140 extending from the device through thecervical canal 164 and cervix to the exterior of the patient's body.Thereafter, an inflation source 125 is connected to the tubular tether140. In one variation the tether is highly elongated and extends throughthe passageway 148 in the introducer 110 and handle 150 together withthe pusher rod 158. In other variations, the tether 140 can be carriedon the outside of the introducer 110. Further, it should be appreciatedthat the tubular tether 140 which is adapted for fluid expansion orinflation of the device 105 can be independent and detachable from thedevice 105 after inflation of the device. In such a case, where thetubular tether 140 is removable, another thread-like tether can beprovided for later withdrawal of the device 105 from the uterine cavity.

FIG. 3D then further illustrates the inflation source 125 that iscoupled to the tubular tether 140 to inflate the anti-adhesion device105. The expansion of the device 105 and uterine cavity can serve as atamponade to stop any bleeding at the treatment site. In the deployedposition of FIG. 3D, the coatings on the device can erode or dissolvestepwise, or layer by layer, with the first pharmacological component ofthe invention (hemostatic agents) being bioavailable immediately andthen terminating after 12 to 24 hours following deployment.

After a first-time interval, which may be from 3 hours to 24 hours, theinflated anti-adhesion device 105 can be deflated through a valve 185 orpressure release mechanism at the proximal end of the tubular tether140. Thereafter, the flattened but still laterally expandedanti-adhesion device 105 can remain in the patient's uterus 114 for asubsequent time interval that can extend to 15 days or to 30 days afterdeployment. Most often, the device would remain deployed for a period oftime ranging from 7 days to 30 days. During such a third time interval,the coatings would provide for timed release of additional anti-crampingdrugs as described above.

Thereafter, referring to FIG. 3E, the anti-adhesion device 105 can beremoved from the uterus 114 by pulling on the tether 140 which collapsesthe spring member 120 and the thin film member 115 to allow itswithdrawal through the cervical canal 164. Generally, method of theinvention prevents adhesions by positioning a mechanical member betweenwalls of the uterus so they cannot adhere to one another, by providing atamponading effect immediately following the surgery, and bypharmacological agents in a timed-release manner to ensure thatadhesions do not occur.

Although particular embodiments of the present invention have beendescribed above in detail, it will be understood that this descriptionis merely for purposes of illustration and the above description of theinvention is not exhaustive. Specific features of the invention areshown in some drawings and not in others, and this is for convenienceonly and any feature may be combined with another in accordance with theinvention. A number of variations and alternatives will be apparent toone having ordinary skills in the art. Such alternatives and variationsare intended to be included within the scope of the claims. Particularfeatures that are presented in dependent claims can be combined and fallwithin the scope of the invention. The invention also encompassesembodiments as if dependent claims were alternatively written in amultiple dependent claim format with reference to other independentclaims.

Other variations are within the spirit of the present invention. Thus,while the invention is susceptible to various modifications andalternative constructions, certain illustrated embodiments thereof areshown in the drawings and have been described above in detail. It shouldbe understood, however, that there is no intention to limit theinvention to the specific form or forms disclosed, but on the contrary,the intention is to cover all modifications, alternative constructions,and equivalents falling within the spirit and scope of the invention, asdefined in the appended claims.

Preferred embodiments of this invention are described herein, includingthe best mode known to the inventors for carrying out the invention.Variations of those preferred embodiments may become apparent to thoseof ordinary skill in the art upon reading the foregoing description. Theinventors expect skilled artisans to employ such variations asappropriate, and the inventors intend for the invention to be practicedotherwise than as specifically described herein. Accordingly, thisinvention includes all modifications and equivalents of the subjectmatter recited in the claims appended hereto as permitted by applicablelaw. Moreover, any combination of the above-described elements in allpossible variations thereof is encompassed by the invention unlessotherwise indicated herein or otherwise clearly contradicted by context.

All references, including publications, patent applications, andpatents, cited herein are hereby incorporated by reference to the sameextent as if each reference were individually and specifically indicatedto be incorporated by reference and were set forth in its entiretyherein.

What is claimed is:
 1. A method of treating a uterine cavity following amedical procedure therein, the method comprising: deploying a devicewithin the uterine cavity in a delivery profile, the device having acontact surface carrying a first pharmacological agent; expanding thedevice to cause the contact surface to move into an expanded profilewhere the contact surface engages a surface of the uterine cavity totamponade a bleeding at the surface of the uterine cavity and such thatthe first pharmacological agent releases from the contact surface intothe surface of the uterine cavity over a first interval; collapsing thedevice to a collapsed profile to provide a barrier between uterinecavity surfaces wherein a second pharmacological agent releases from thecontact surfaces over a second interval; and removing the device afterthe second interval.
 2. The method of claim 1, where the second intervalbegin after the first interval ends.
 3. The method of claim 1, whereinthe first pharmacological agent is selected from a group constating of ahemostatic agent, an analgesic agent, an anti-cramping agent, and anon-steroidal anti-inflammatory agent.
 4. The method of claim 1, whereinthe second pharmacological agent is selected from a group consisting ofan anti-adhesion agent, an analgesic agent, an anti-cramping agent, anda non-steroidal anti-inflammatory agent.
 5. The method of claim 1,wherein the uterine cavity comprises an area of damaged produced by atherapeutic procedure.
 6. The method of claim 5, wherein the area ofdamaged tissue is produced by a procedure selected form a groupconsisting of resection, curettage and ablation.
 7. The method of claim1, wherein deploying the device includes trans-cervically introducing anelongate introducer into the uterine cavity and deploying the devicefrom a passageway in the elongate introducer.
 8. The method of claim 1,wherein deploying the device includes allowing a spring-like element inthe device to expand the device to a triangular shape in the uterinecavity.
 9. The method of claim 1, wherein deploying the device includesremoving introducer from a uterus and a cervix and leaving a tetherextending through a cervical canal, where the tether is connected to thedevice.
 10. The method of claim 1, wherein expanding the device includesinflating the device with a fluid injected through a lumen of a tethercoupled to an interior chamber of the device.
 11. The method of claim10, further comprising maintaining the device in the expanded profilefor the first interval by sealing the lumen of the tether.
 12. Themethod of claim 11, wherein sealing the lumen of the tether comprisesactuating a stop mechanism in a portion of the tether outside theuterine cavity.
 13. The method of claim 12, wherein releasing the devicecomprises actuating the stop mechanism to unseal the lumen.
 14. Themethod of claim 1, wherein the first interval comprises 24 hours orless.
 15. The method of claim 1, wherein the second interval comprises28 days from an end of the first interval.
 16. The method of claim 1,further comprising injecting at least one additional pharmacologicalagent through a second tether channel into the uterine cavity.
 17. Themethod of claim 1, further comprising removing the device from theuterine cavity after the second interval.
 18. The method of claim 17,wherein removing the device comprises pulling a tether coupled to thedevice outwardly from a cervical canal and uterine cavity.
 19. A deviceconfigured for temporary implantation in a uterine cavity following amedical procedure therein, the device comprising: a tissue contactingstructure being moveable between a deployment configuration, acollapsed, configuration, and an expanded configuration in which thetissue contacting structure engages a surface of the uterine cavity;where the tissue contacting structure comprises a thin film memberdisposed around a spring element; and at least one pharmacological agentlocated on or in the thin film member and configured to be releasablefrom a surface of the thin film member over a time release interval. 20.The device of claim 19, wherein a pharmacological agent is a hemostaticagent.
 21. The device of claim 19, wherein a pharmacological agent isselected from a group of an anti-inflammatory agent, an analgesic, ananti-cramping agent or an anti-adhesion agent.
 22. The device of claim19, wherein the thin film member has a fluid tight interior chamber toallow inflation of the thin film member.
 23. The device of claim 19,further comprising an elongated tether couple to the device.
 24. Thedevice of claim 23, where the elongated tether has an inflation balloontherein adapted for coupling to an inflation source.